METADATA
last updated: 2026-03-04 by BA
file_name: 2020-03-31_FDA Website - EUA for Molecular Diagnostic Tests.md
file_date: 2020-03-31
title: FDA Website - EUA for Molecular Diagnostic Tests
category: regulatory
subcategory: fda-policy
tags: 
source_file_type: website
xfile_type: NA
gfile_url: NA
xfile_github_download_url: NA
pdf_gdrive_url: NA
pdf_github_url: NA
conversion_input_file_type: docx
conversion: manual cut and paste
license: Public Domain
tokens: 285
words: 170
notes: date converted 2024-03-27
web_url: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#umbrella-molecular
summary_short: The FDA umbrella EUA for molecular laboratory-developed tests (LDTs) for SARS-CoV-2 outlines eligibility criteria, including CLIA high-complexity certification and use limited to the single developing laboratory, with authorized tests listed in Appendix A. It also notes the November 15, 2021 reissuance that limited authorization to tests already in Appendix A and provides links to the authorization letter and provider/patient fact sheets.


CONTENT

On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.  Tests authorized under this umbrella EUA were added to Appendix A in the table below. 

On November 15, 2021, the FDA reissued this EUA such that only tests that are listed in Appendix A are authorized for use as described in the EUA, and no additional tests will be authorized by this EUA.  The reissued EUA also includes updated Conditions of Authorization and Fact Sheets to reflect the most up-to-date information.

EUA Letter of Authorization - [Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19)](https://www.fda.gov/media/136598/download?attachment)
Fact Sheet for [Healthcare Providers](https://www.fda.gov/media/136599/download?attachment)
Fact Sheet for [Patients](https://www.fda.gov/media/136600/download?attachment)